The ISS Blog

Providing Scientific Stewardship to the Healthcare Industry and Counsel.

FDA Committee Discusses Potential Pediatric Applications for Adult Cancer Products Currently Under Development
17 October 2017
FDA Committee Discusses Potential Pediatric Applications for Adult Cancer Products Currently Under Development

On June 21st & 22nd, the Oncologic Drugs Advisory Committee (ODAC) explored pediatric development plans, to gauge investigator interest, for multiple products currently under development for adult cancer indications. Read more

FDA’s Arthritis Advisory Committee Does Not Recommend Sirukumab For Treatment Of Moderately To Severely Active Rheumatoid Arthritis
13 October 2017
FDA’s Arthritis Advisory Committee Does Not Recommend Sirukumab For Treatment Of Moderately To Severely Active Rheumatoid Arthritis

On August 2nd, the U.S. Food and Drug Administration’s Arthritis Advisory Committee (AAC) discussed biologics license application (BLA) 761057, for sirukumab (proposed trade name PLIVENSIA™) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Read more

FDA Votes in Favor of Additional Indication for Novo Nordisk’s VICTOZA
12 October 2017
FDA Votes in Favor of Additional Indication for Novo Nordisk’s VICTOZA

On June 20th, 2017, the Endocrinological and Metabolic Drugs Advisory Committee (EMDAC) discussed the supplemental new drug application (sNDA) 022341,  for Novo Nordisk’s VICTOZA® (liraglutide injection) which outlined an additional indication for the product. Read more

HEARTBEARN, HEADACHES, AND HANGOVERS: THE DECISION TO REFORMULATE ANALGESIC COMBINATION PRODUCTS. HOW DOES THE FDA WEIGH-IN?
06 October 2017
HEARTBEARN, HEADACHES, AND HANGOVERS: THE DECISION TO REFORMULATE ANALGESIC COMBINATION PRODUCTS. HOW DOES THE FDA WEIGH-IN?

On April 4th, the Nonprescription Drugs Advisory Committee (NDAC) discussed safety issues associated with over-the-counter (OTC) analgesic combination products used for indications such as upset stomach (i.e. heartburn, nausea, bloating, belching, gas, dyspepsia, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid OTC monograph. Read more

FDA Panel Recommends Approval of Genentech’s rituximab/hyaluronidase Injection
04 October 2017
FDA Panel Recommends Approval of Genentech’s rituximab/hyaluronidase Injection

On March 29th, the Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 761064 for rituximab/hyaluronidase injection (Rituximab SC), submitted by Genentech, Inc. Read more

Effective Use of Scientific Principles in The Courtroom: From Silicone to Talc and Beyond
30 August 2017
Effective Use of Scientific Principles in The Courtroom: From Silicone to Talc and Beyond

Nathan Schachtman is a lawyer with a deep respect and passion for the rigorous application of science in toxic tort and pharmaceutical and medical device litigation. Read more

Opiate Litigation: What’s on the Horizon?
22 August 2017
Opiate Litigation: What’s on the Horizon?

In 1996, James Campbell, a neurosurgeon at Johns Hopkins Medical School, gave a keynote speech at the American Pain Society’s annual conference. Campbell argued that hospitals must change their views on pain management by treating it as “The Fifth Vital Sign,” elevating it to the importance of collecting standard signs and symptoms (e.g., blood pressure, temperature, heart rate, and respiratory rate) as part of a standard medical exam. Read more

How E-Cigarettes Are Viewed by Young Adults and Are They Effective?
11 July 2017
How E-Cigarettes Are Viewed by Young Adults and Are They Effective?

Maintaining a comprehensive and continuous awareness of the science is critical to any winning legal strategy – especially when it comes to cases involving products like electronic cigarettes (e-cigarettes) where the science is constantly changing and emerging. Read more

The Importance of Attributable Risk in Toxic Tort Litigation
05 July 2017
The Importance of Attributable Risk in Toxic Tort Litigation

From a scientific standpoint, toxic tort cases, are about attributing a specific injury to a specific exposure. How can plaintiffs appropriately identify those individuals whose exposure was responsible for an injury? Or, alternatively, how can the defense identify those individuals whose exposure was not responsible for an injury. Read more

Using Genomics to Prevail in Toxic Tort Litigation
19 June 2017
Using Genomics to Prevail in Toxic Tort Litigation

Over the past several decades, genomic science revolutionized the practice of criminal law and is now in the process of transforming civil law. While the use of genetic science in criminal law tended to focus on relatively narrow issues, the genetic revolution in civil law is likely to lead to far wider ranging implications, including causation, foreseeability, compensation, ethics and risk management. Read more

Presenting The Science Is Key In Talc Trials
13 June 2017
Presenting The Science Is Key In Talc Trials

Establishing a rigorous and reliable causal inference between an exposure and an adverse health outcome is one of the most difficult things to do in the health sciences. However, it is sometimes even more difficult to effectively and appropriately demonstrate that a causal relationship does not exist. Read more

Streaming Video Testimony Sheds Light on Role of Science in California Talc Litigation
05 June 2017
Streaming Video Testimony Sheds Light on Role of Science in California Talc Litigation

Every February 28th, India celebrates National Science Day in honor the  Indian physicist Sir Chandrashekhara Venkata, who discovered the Raman effect. The United States has no equivalent celebration, but “Science Days” have become a commonplace in complex state and federal Litigations, around the country. Read more

FDA Panel Recommends Approval Of Actavis’ Ceftazidime-Avibactam
13 April 2017
FDA Panel Recommends Approval Of Actavis’ Ceftazidime-Avibactam

Ceftazidime-avibactam is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections in hospitalized patients when limited or not treatment options are available. Read more

Explosive Growth of e-Cigarette Science
04 April 2017
Explosive Growth of e-Cigarette Science

It is our experience that many attorneys and their teams struggle to keep up with new science in a systematic and organized fashion. However, we have also encountered scientific savvy firms that are up-to-date on the science and hard at work analyzing and developing new legal strategies based on the emerging science. This latter group is best-positioned to provide their clients with the best science-based defense. Read more

Meeting Announcement – Vimizim (elosulfase alfa)
02 April 2017
Meeting Announcement – Vimizim (elosulfase alfa)

The committee will discuss biologics license application (BLA) 125460, for Vimizim (elosulfase alfa), manufactured by BioMarin Pharmaceutical, Inc., for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Read more

Experts On The Experts: A Deep Dive Into The Make-or-Break Scientific Testimony Deciding Talc Powder Trials
09 March 2017
Experts On The Experts: A Deep Dive Into The Make-or-Break Scientific Testimony Deciding Talc Powder Trials

Expert testimony is often a critical component to prevailing in high stakes litigation.  Finding and vetting the ideal expert can be a challenge for the trial team but developing expert witnesses can be the difference between a positive outcome and costly defeat.  Likewise, preparing for the cross examination of opposing experts is equally important and can be one of the most vexing obstacles on the way to victory. Read more

Will EU Regulatory Battles Over Endocrine Disruptors Translate to US Litigation?
03 March 2017
Will EU Regulatory Battles Over Endocrine Disruptors Translate to US Litigation?

There is a battle raging in the European Union on an issue that is recognized in the US only by environmental scientists, policy wonks, and activists: the regulatory status of endocrine disrupting chemicals. Read more

USING GENOMICS TO PREVAIL IN YOUR NEXT TOXIC TORT CASE
15 February 2017
USING GENOMICS TO PREVAIL IN YOUR NEXT TOXIC TORT CASE

As any good toxic tort litigator knows, it is not enough for a defendant to demonstrate that the alleged harmful chemical was not the cause of the injury. Rather, an effective defense provides the jury with a reasonable explanation as to what the cause of the injury was. Read more